Breakthrough as FDA approves non-hormonal menopause pill
The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.
What you need to know:
- The US Food and Drug Administration has approved the first non-hormonal drug to alleviate moderate to severe hot flashes associated with menopause.
- The once-daily pill could prove a game changer for women unable to undergo hormone replacement therapy (HRT) due to underlying health conditions.
A new era in menopausal care is on the horizon, with the US Food and Drug Administration (FDA) approving the first non-hormonal drug, fezolinetant, to alleviate moderate to severe hot flashes associated with menopause. Sold under the brand name Veozah, the once-daily pill could prove a game changer for women unable to undergo hormone replacement therapy (HRT) due to underlying health conditions.
Dr Janet Maynard, director of the Office of Rare Diseases, Paediatrics, Urologic and Reproductive Medicine at the FDA's Centre for Drug Evaluation and Research, lauds the breakthrough.
"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," she said.
Hot flashes
"The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women."
Until now, women suffering from hot flashes had to rely on HRT and certain antidepressants, both of which carry side effects and health risks. Veozah, however, works differently; by targeting the brain's temperature control centre, it reduces both the frequency and severity of hot flashes.
Menopause typically starts 12 months after a woman's last period and can last several years. Symptoms range from hot flashes and night sweats, to lesser-known issues like anxiety, insomnia, joint pain, and decreased sexual function. Genetics, autoimmune conditions, trauma to the ovaries, and toxic exposure can all influence when a woman enters menopause.
Menopause transition
Marci English, vice-president and head of biopharma development at Astellas Pharma, the company behind Veozah, highlighted the importance of this non-hormonal therapy.
"One part when we talk about menopause I think is so overlooked … the menopause transition is seven years on average. If we look at women overall, 60 to 80 per cent of women are going to experience hot flashes during the menopause transition," she told ABC News.
Dr Jessica Shepherd, a board-certified OBGYN and chief medical officer for Verywell Health, said the FDA's approval of fezolinetant could be "revolutionary" in the menopause landscape.
Clinical trials suggest that fezolinetant could reduce hot flashes by more than 50 per cent in most women. While patients will need to undergo routine bloodwork for the first nine months of treatment, the most common side effects are reportedly manageable and include abdominal pain, diarrhoea, insomnia, and back pain.
Astellas Pharma expects Veozah to hit pharmacy shelves within three weeks. The company estimates the drug will cost $550 for a 30-day supply at the wholesale level, but actual prices for consumers, especially those with insurance, are likely to be lower. With this innovative approach to treating menopause symptoms, a new era of women's health is dawning.
